QC Analyst II (Contract)
Adverum is looking for a Quality Control Analyst Temp to Hire (6-month contract) to join our team in our Redwood City office. This position directly reports to the Quality Management or QC Lead. This person will be working with the QC team and cross-functionally. This individual will be a crucial member of the Quality Control team, contributing to the development and performance Quality Control (QC) methods, systems, policies, processes, procedures, and controls as they relate to the analytical testing of clinical materials.
What you'll do:
- Performs release, stability, and in-process testing of materials, samples, and final products.
- The Quality Control Analyst is responsible in performing cell culture activities, maintaining aseptic techniques to support cell-based assays.
- Maintain Data Integrity and ensure compliance with SOP’s and cGMP requirements.
- Participates in Lab Operation Activities including Inventory management, CAL/PM coordination, stocking of labs and assistance with equipment PMs.
- Support continuous improvement projects in the QC Laboratories such as 6S and Kaizen.
- Assists in writing, reviewing, and revising SOPs.
- Performs analysis and interpretation of test results, and data trending, identifies deviations, and makes appropriate recommendations.
- Participates in the peer review of QC Test Data.
- Participates in method and equipment qualification/validation studies; generates protocols, executes, coordinates assays, and drafts reports.
- Other responsibilities may be assigned as needed.
- Relevant scientific degree with minimum 2 years of experience in a bio-pharma analytical laboratory.
- Experience with mammalian cell culture is required and insect cell culture is a plus.
- Experience with qPCR, SDS-PAGE methods is a plus.
- Experience with mammalian or cell-based assays is a plus.
- Experience in quality control desired. A strong background in molecular biology is desired. Experience with viral vector (adeno-associated virus) product is a plus.
- Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries desired. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative and/or digital PCR, ELISA, and cell-based methods.
- Knowledge of statistical methods applicable to the analysis of experimental data.
- Proficient in general and non-routine laboratory skills.
- Excellent interpersonal, communication and organizational skills.
- Flexibility in problem solving to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as ImageLab, QuantStudio 6, Soft Max Pro desired.
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation